Insulin glargine supplementation during early management phase in children with diabetic ketoacidosis: a double-blinded randomised controlled trial.

Abstract

To evaluate the efficacy and safety of early supplementation with insulin glargine (GI) during the acute management of paediatric diabetic ketoacidosis (DKA). Double-blinded randomised controlled trial conducted from July 2022 to June 2023. Emergency department and paediatric intensive care unit of a tertiary care teaching hospital in North India. Children between >1 month and ≤12 years presenting with DKA. Participants were randomised to receive a single subcutaneous dose of GI (0.3 U/kg) or volume-matched placebo within 1 hour of initiating intravenous regular insulin infusion. The primary outcome was time to DKA resolution. Secondary outcomes included the rate of blood glucose decline, incidence of hypoglycaemia, hypokalaemia, rebound hyperglycaemia, treatment failure and total regular insulin dose received. 82 children were enrolled (glargine: n=42; control: n=40). The mean (SD) time to DKA resolution was 11 (6.4) hours in the glargine group versus 13.9 (7.4) hours in the control group (adjusted HR 1.05, 95% CI 0.65 to 1.69, p=0.84). Rebound hyperglycaemia (adjusted risk ratio (ARR) 0.57, 95% CI 0.35 to 0.92, p=0.02) and treatment failure (ARR 0.14, 95% CI 0.04 to 0.56, p=0.005) were significantly lower with glargine. Other secondary outcomes were similar across groups. While early glargine supplementation did not accelerate DKA resolution, it was associated with reduced treatment failure and improved glycaemic stability post resolution. Its use was safe, feasible and not linked to increased adverse events. CTRI/2022/06/043076.